BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEORAPTOR

    MDR report key: 3142344 · Received June 3, 2013

    Report

    Report Number
    1219602-2013-00120
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 3, 2013
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING A SHOULDER INSTABILITY PROCEDURE THE SURGEON WAS USING A 2.3MM OSTEORAPTOR SUTURE ANCHOR, INTRA-OPERATIVE THE ANCHOR REPORTEDLY BROKE UPON INSERTING INTO THE PATIENTS BONE. THE ANCHOR WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. SITE PREPARATION AND PATIENT BONE QUALITY WAS NOT PROVIDED. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243342 OSTEORAPTOR OSTEORAPTOR 2.3 W. UB COBRAID BLUE MAI SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 50403712

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR